Discovery Elbow Long-Term Survivorship

Discovery Elbow Long-Term Survivorship Study

The Discovery™ Elbow Multi-Center Prospective Study (5-year Study) patients will be consented at the two year or next scheduled follow-up period for the early-enrolled patients.

Study Overview

• Status: Terminated
• Conditions: Pain; Survivorship
• Intervention / Treatment: Device: Discovery elbow minimally constrained

Detailed Description

Eligibility: Patient(s) must be enrolled in the Discovery Multi-Center Prospective Study. The patient must consent to participation in the Discovery Long-term Survivorship Study.

In order to continue to follow the multi-center subjects long-term Biomet would like to extend the follow-up to include annual follow-ups from 10 to 15 years to document long-term survivorship. The annual follow-up will be obtained by sending annual questionnaire directly to the patients by mail. The Patient ASES questionnaire and survivorship data questions will be collected.

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33637
      • Florida Orthopedic Institute
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • The Indiana Hand to Shoulder Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Hand Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The Study population shall be participanting in the Discovery Elbow Multi-center Study who provide consent for the Discovey Elbow Long-term Survivoship Study

Description

Inclusion Criteria:

1. Participant in the Discovery Elbow Multi-center Study
2. Consent to participate in the Discovery Elbow Long-Term Survivorship Study

Exclusion Criteria:

1. Patient is not a Discovery Elbow Multi-center Participant
2. Patient does not provide consent for the Discovery Elbow Long-term Survivorship Study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Derived American Shoulder and Elbow Society (ASES) Pain Score	This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best)	10 Years Post-op
Patient Derived American Shoulder and Elbow Society (ASES) Function	This is the patient's perception of function. The maximum score is 36 and the minimum score is 0. The maximum score represents maximum function.	10 Years Post-op
Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction	This is the patient's perception of satisfaction with the elbow replacement surgery. Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction.	10 Years Post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship Will be Measured by the Incidence of Revision or Removals	The consented Patient will answer specific questions about their elbow replacement such as; if the elbow replacement has been removed	10 years Post-op

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Russell Schenck, PhD, Director Clinical Research, Biomet Orthopedics, LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: July 23, 2010
• First Submitted That Met QC Criteria: March 2, 2011
• First Posted (Estimate): March 4, 2011

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: March 20, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: elbow long-term Survivorship; Study participant Discovery Elbow Multi-center Study who; consent for the Discovery Elbow Long-term SurvivorshipStudy
• Other Study ID Numbers: ORTHO.CR.EX002